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510(k) K944827

OREX SURGEON'S GOWN by Thantex Specialties, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1995
Date Received
September 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Thantex Specialties, Inc.

  • K970547 — ISOLYSER SDS SHARPS CONTAINER (July 18, 1997)
  • K961083 — OREX SURGEON'S VEST (August 23, 1996)
  • K942200 — ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS (August 7, 1995)
  • K943626 — ISOLYSER SHARPS MANAGEMENT SYSTEM SMS (June 16, 1995)
  • K945755 — OREX(R) O.R EQUIPMENT DRAPES (May 25, 1995)
  • K945223 — OREX ISOLATION GOWN (April 25, 1995)
  • K944859 — OREX SURGICAL DRAPES (February 28, 1995)
  • K943034 — OREX SHOE COVERS (January 2, 1995)
  • K942228 — OREX O.R. TOWEL (December 20, 1994)
  • K940767 — OREX (12X12 X-RAY DETECTABLE) (December 19, 1994)

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